US20100249919A1 - Pre-sized prosthetic chordae implantation system - Google Patents

Abstract

A pre-sized prosthetic chordae assembly includes a male attachment unit and a female securing member. The male attachment unit includes a plurality of pre-sized prosthetic chordae fixedly connected to at least one male attachment member and a papillary muscle penetration member that is connected to and extends substantially axial to the at least one male attachment member. The female securing member is for receiving the papillary penetration member.

Description

RELATED APPLICATION
• This application claims priority from U.S. Provisional Patent Application Ser. No. 61/164,937, filed Mar. 31, 2009, the subject matter of which is incorporated hereby incorporated by reference in its entirety.
TECHNICAL FIELD
• The present invention relates to cardiac valve repair, and more particularly to a pre-sized prosthetic chordae assembly (PCA) and apparatus for implanting the pre-sized PCA to repair mitral and tricuspid valves.
BACKGROUND OF THE INVENTION
• Heart valve replacement is a well known procedure in which an artificial heart valve prosthesis is implanted in place of a diseased or malfunctioning heart valve. Heart valve prostheses may be mechanical or bioprosthetic. Use of mechanical valves typically requires extensive anticoagulation therapy. The need for anticoagulation therapy can be avoided in general by the use of artificial biological heart valves, such as bovine xenografts. Nevertheless, dystrophic calcification with subsequent degeneration is the major cause of failure of such bioprostheses in the long term.
• When mitral or tricuspid valve replacement is performed, the chordae tendineae are cut, thus leaving the geometry and function of the ventricle impaired and in need of reconstruction. As an alternative to conventional heart valve replacement operations, diseased and malfunctioning chordae can be repaired by surgically replacing diseased heart chordae with artificial chordae. One known way of replacing a malfunctioning chordae uses a simple suture with a needle on each end of the suture. The suture is stitched through the papillary muscle and secured thereto with a knot. The two ends of the suture are then similarly stitched through the free ends of the valve leaflets.
• Operations to repair heart valve chordae are technically demanding. For example, when a second knot is needed to secure the suture to the valve leaflets, the length of the suture spanning the distance between the papillary muscle and the valve leaflet is likely to change since there is nothing holding the suture in place. This complication increases the skill and time required to perform the procedure. Moreover, the valve will not function properly if the length of the artificial chordae between the papillary muscle and valve leaflet is overly long or overly short.
SUMMARY OF THE INVENTION
• According to one aspect of the present invention, a pre-sized prosthetic chordae assembly includes a male attachment unit and a female securing member. The male attachment unit includes a plurality of pre-sized prosthetic chordae fixedly connected to at least one male attachment member and a papillary muscle penetration member that is connected to and extends substantially axial to the at least one male attachment member. The female securing member is for receiving the papillary penetration member.
• According to another aspect of the present invention, an apparatus is provided for implanting a pre-sized prosthetic chordae assembly in a subject. The apparatus comprises a proximal handle, a distal applicator end, and an actuating mechanism. The distal applicator end is operably linked to the proximal handle via an intermediate portion that defines a longitudinal axis. The distal applicator end comprises opposable first and second jaw members. Each of the first and second jaw members includes a port for receiving the pre-sized prosthetic chordae assembly. The actuating mechanism extends between the proximal handle and the distal applicator end. The actuating mechanism is for actuating the second jaw member.
• According to another aspect of the present invention, a method is provided for implanting a pre-sized prosthetic chordae assembly in a subject. One step of the method includes providing a pre-sized prosthetic chordae assembly. The pre-sized prosthetic chordae assembly includes a male attachment unit comprising a plurality of pre-sized prosthetic chordae fixedly connected to at least one male attachment member and a papillary muscle penetration member that is connected to and extends substantially axial to the at least one male attachment member. An apparatus for implanting the pre-sized prosthetic chordae assembly is also provided. The apparatus comprises a proximal handle, a distal applicator end operably linked to the proximal handle, and an actuating mechanism. The distal applicator end comprises opposable first and second jaw members. The actuating mechanism extends between the proximal handle and the distal applicator end. The female securing member and the male attachment unit are loaded onto the first and second jaw members, respectively. Next, the distal applicator end is positioned about a papillary muscle so that the first and second jaw members are disposed about opposite sides of the papillary muscle. The proximal handle is then operated to actuate the second jaw member such that the papillary penetration member pierces the papillary muscle and is received by the female securing member. The distal applicator end is retracted so that the female securing member and the male attachment unit are slidably removed from the first and second jaw members, respectively, and remain implanted in the subject.
BRIEF DESCRIPTION OF THE DRAWINGS
• The foregoing and other features of the present invention will become apparent to those skilled in the art to which the present invention relates upon reading the following description with reference to the accompanying drawings, in which:
• FIG. 1A is a perspective view of a pre-sized prosthetic chordae assembly (PCA) constructed in accordance with one aspect of the present invention;
• FIG. 1B is a perspective view of an apparatus for implanting the pre-sized PCA ofFIG. 1A in a subject constructed in accordance with another aspect of the present invention;
• FIG. 2A is an enlarged perspective view of the pre-sized PCA shown inFIG. 1A;
• FIG. 2B is a perspective view showing a prosthetic chordae of the pre-sized PCA inFIG. 2A;
• FIG. 2C is a cross-sectional view taken along Line2C-2C inFIG. 2A;
• FIG. 2D is a cross-sectional view showing the pre-sized PCA ofFIG. 2C in an exploded configuration;
• FIG. 3 is a perspective view showing an alternative configuration of the apparatus inFIG. 1B;
• FIG. 4 is a magnified perspective view showing a distal applicator end of the apparatus inFIG. 1B;
• FIG. 5 is an exploded perspective view of the apparatus inFIG. 1B;
• FIG. 6A is a side view showing an actuating mechanism of the apparatus inFIG. 1B;
• FIG. 6B is a magnified side view showing a distal end of the actuating mechanism inFIG. 6A;
• FIG. 7 is a process flow diagram illustrating a method for implanting a pre-sized PCA in a subject according to another aspect of the present invention;
• FIG. 8 is a perspective view showing the pre-sized PCA ofFIG. 1A loaded onto the distal applicator end;
• FIG. 9 is a perspective view showing the distal applicator end inFIG. 8 positioned about a papillary muscle;
• FIG. 10 is a perspective view showing the distal applicator end engaging the papillary muscle inFIG. 9;
• FIG. 11 is a perspective view showing the distal applicator end being retracted from the papillary muscle inFIG. 10; and
• FIG. 12 is a perspective view showing the pre-sized PCA secured to the papillary muscle inFIG. 11.
DETAILED DESCRIPTION
• The present invention relates to cardiac valve repair, and more particularly to a pre-sized prosthetic chordae assembly (PCA) and apparatus for implanting the pre-sized PCA to repair mitrel and tricuspid valves. As representative of the present invention,FIGS. 1A-B illustrate a pre-sized PCA10 (FIG. 1A) and an apparatus12 (FIG. 1B) for implanting the pre-sized PCA in a subject. Although the present invention is described herein as being useful for treating a dysfunctional mitral valve (not shown), it should be appreciated that other cardiac valves, such as the tricuspid valve (not shown) are also treatable using the present invention.
• Referring toFIGS. 2A-D, one aspect of the present invention includes apre-sized PCA10. As shown inFIG. 2A, thepre-sized PCA10 comprises amale attachment unit14 and afemale securing member16 for receiving a papillarymuscle penetration member18 of the male attachment unit. Themale attachment unit14 comprises a plurality of pre-sized prosthetic chordate20 fixedly connected to at least one male attachment member13. The pre-sizedprosthetic chordae20 can be identically or similarly constructed as those described in U.S. patent application Ser. No. 12/238,322, filed Sep. 28, 2007, the entirety of which is hereby incorporated by reference.
• As shown inFIG. 2A, each of the pre-sizedprosthetic chordae20 includes afirst end portion22, asecond end portion24, and a middle portion26 extending between the first and second end portions. Each of the pre-sizedprosthetic chordae20 is comprised of a plurality ofloop members28 arranged in a daisy chain or ladder-like configuration. Each of theloop members28 comprises two generallyparallel strands30 and includes first and second ends32 and34 respectively defining first and secondarcuate junctions36 and38. The distance between the first and secondarcuate junctions36 and38 is about1 cm; however, it should be appreciated that the distance between the first and second arcuate junctions will depend upon anatomical variation between subjects. The two generallyparallel strands30 are fluidly connected to the first and secondarcuate junctions36 and38 of eachloop member28. Eachloop member28 has a size and length that is substantially equal to the size and length of the other loop members.
• FIG. 2B illustrates one example of a pre-sizedprosthetic chordae20 having a ladder-like configuration. InFIG. 2B, the pre-sized prosthetic chordate20 can comprise a continuousfirst strand180 of a material (e.g., a suture) having an arcuatefirst end portion22 and asecond end portion24 that is formed into aknot182. At least onerung184 is axially-spaced between the first andsecond end portions22 and24 of thefirst strand180. As shown inFIG. 2B, each of therungs184 includes first and second ends186 and188 that are securely connected to thefirst strand180 by first andsecond knots180′ and180″. Therungs184 can be made of any biocompatible material, such as suture material. During implantation of thepre-sized PCA10, thefirst strand180 can be cut at a plurality of points (indicated by “X”) to quickly and easily adjust the length of theprosthetic chordae20 so that the pre-sized PCA optimally conforms to the cardiac anatomy of the subject.
• Eachloop member28 is made from a relatively elastic and flexible biocompatible material. Examples of such biocompatible materials can include Teflon and expanded polytetrafluoroethylene (ePTFE). ePTFE, for example, may be suture material or fabric material. Besides Teflon and ePTFE, it should be apparent to one skilled in the art that there are other suitable biocompatible materials, such as those frequently used to form sutures.
• Each of the pre-sizedprosthetic chordae20 comprises an elongated, unitary unit of fourinterconnected loop members28. Each of the pre-sizedprosthetic chordae20 is comprised of a single strand or fiber, such as a suture; however, it should be appreciated that the pre-sized prosthetic chordae may be comprised of multiple units, e.g., multiple sutures. Where each of the pre-sizedprosthetic chordae20 is comprised of multiple sutures, for example, each of the sutures can be fixedly joined to form each of theloop members28. It should also be appreciated that any number ofloop members28 can be used to form the pre-sizedprosthetic chordae20. Accordingly, each of the pre-sizedprosthetic chordae20 is adjustable to a pre-determined length by adding or removing any desired number ofloop members28.
• As noted above, themale attachment unit14 comprises a plurality of pre-sized prosthetic chordate20 fixedly connected to at least one male attachment member13. In one aspect of present invention, each of the pre-sized prosthetic chordae20 (FIG. 2A) is fixedly sandwiched between a firstmale attachment member40 and a secondmale attachment member42. The firstmale attachment member40 comprises a pledget having first andsecond surfaces44 and46 (FIG. 2D). The firstmale attachment member40 can be made of any medical grade material, such as a durable fibrous material (e.g., gauze) or polymer (e.g., ePTFE). As shown inFIG. 2A, the firstmale attachment member40 additionally includes a rigid orsemi-rigid backing48 for supporting the papillarymuscle penetration member18. Thebacking48 can be comprised of a hardened polymer, for example, that extends across all or a portion of thesecond surface46 of the firstmale attachment member40.
• The secondmale attachment member42 comprises a pledget having by first andsecond surfaces50 and52 (FIG. 2D). The secondmale attachment member42 can be made of any medical grade material, such as a durable fibrous material (e.g., gauze) or polymer (e.g., ePTFE). The secondmale attachment member42 includes at least one channel54 (FIG. 2A) that extends between the first andsecond surfaces50 and52 and is capable of receiving the papillarymuscle penetration member18. As shown inFIG. 2D, each of the pre-sizedprosthetic chordae20 is securely attached to thefirst surface50 of the secondmale attachment member42 using sutures or clips (not shown), for example. It will be appreciated, however, that each of the pre-sizedprosthetic chordae20 may be securely attached to thesecond surface52 of the firstmale attachment member40.
• As noted above, themale attachment unit14 also includes a papillarymuscle penetration member18 for penetrating a papillary muscle56 (FIG. 9). The papillary muscle penetration member18 (FIG. 2D) can comprise a needle having a proximal end58 and a sharpened distal tip60. Where the papillarymuscle penetration member18 comprises a needle, the needle can have any desired gauge between10 and33. As shown inFIG. 2D, the proximal end58 of the papillarymuscle penetration member18 is securely connected to thesecond surface46 of the firstmale attachment member40. It will be appreciated, however, that the proximal end58 of the papillarymuscle penetration member18 can be disposed between the first andsecond surfaces44 and46 of the firstmale attachment member40.
• As shown inFIG. 2D, thefemale securing member16 of thepre-sized PCA10 comprises a pledget having by first andsecond surfaces62 and64. Thefemale securing member16 can be made of any suitable medical grade material, such as a durable fibrous material (e.g., gauze) or polymer (e.g., ePTFE). Thefemale securing member16 includes at least one channel66 that extends between the first andsecond surfaces62 and64 and is capable of receiving the papillarymuscle penetration member18. Thesecond surface64 of the female securingmember16 also includes aprotective member68 to prevent the distal tip60 of the papillarymuscle penetration member18 from damaging cardiac structures once thepre-sized PCA10 is implanted. Theprotective member68 can include a piece of cotton or gauze, for example, that is integrally formed with or securely attached to thesecond surface64 of the female securingmember16. Alternatively, theprotective member68 can comprise a deformable backing that bubbles outward when the distal tip60 of the papillarymuscle penetration member18 extends through the channel66.
• As shown inFIG. 1B andFIGS. 3-6B, another aspect of the present invention includes anapparatus12 for implanting the pre-sized PCA10 (FIG. 2A) in a subject. The apparatus12 (FIG. 1B) comprises aproximal handle70 operably linked to adistal applicator end72 via an elongatedintermediate portion74. The elongatedintermediate portion74 defines a longitudinal axis LA that extends between theproximal handle70 and thedistal applicator end72. Thedistal applicator end72 of theapparatus12 includes first andsecond jaw members76 and78 adapted to deliver the female securing member16 (FIG. 2A) and themale attachment unit14, respectively. As described in more detail below, an actuating mechanism80 (FIG. 5) for actuating the second jaw member78 (FIG. 1B) extends between theproximal handle70 and thedistal applicator end72 of theapparatus12.
• Referring toFIG. 1B, theproximal handle70 includes ahandle member82 that extends substantially perpendicular to the longitudinal axis LA and alever84. Thelever84 is movable from a first position to a second position (indicated by dashed line). Using tactile force, for example, movement of thelever84 from the first position to the second position is used to operate theactuating mechanism80 and thereby actuate thesecond jaw member78.
• It will be appreciated that theproximal handle70 can have other configurations besides the one shown inFIG. 1B. As shown inFIG. 3, for example, theproximal handle70 can be constructed so that both thehandle member82 and thelever84 extend substantially parallel to the longitudinal axis LA of theapparatus12. Additionally, theproximal handle70 can include an adjustment mechanism86 (e.g., a knob) to control rotation of thedistal applicator end72 about the longitudinal axis LA. For example, theadjustment mechanism86 can be manipulated to cause thedistal applicator end72 to rotate in a clock-wise or counter-clockwise direction relative to the longitudinal axis LA to facilitate implantation of thepre-sized PCA10.
• As noted above, thedistal applicator end72 of theapparatus12 includes opposable first andsecond jaw members76 and78 (FIG. 4). Each of the first andsecond jaw members76 and78 includes aproximal end88 and adistal end90. Thedistal end90 of each of the first andsecond jaw members76 and78 includes first andsecond ports92 and94, respectively, for receiving the female securing member16 (FIG. 2A) and themale attachment unit14. Each of the first andsecond ports92 and94 (FIG. 4) is defined by first andsecond openings96 and98, each of which are in fluid communication with opposinglongitudinal slots100. Thesecond opening98 of thesecond jaw member78 is adapted to receive the firstmale attachment member40, and thefirst opening96 of thefirst jaw member76 is adapted to receive thefemale securing member16. Each of thelongitudinal slots100 is adapted to receive the papillarymuscle penetration member18 and extends along a portion of thedistal end90 of the first andsecond jaw members76 and78.
• FIG. 5 is an exploded view of theapparatus12 inFIG. 1B showing the components of theactuating mechanism80, as well asmultiple housing components102 used to house the actuating mechanism. As shown inFIG. 5, theactuating mechanism80 extends between theproximal handle70 and thedistal applicator end72 of theapparatus12. Theactuating mechanism80 comprises first and second L-shapedarm members104 and106, each of which has aproximal end108 and adistal end110. Theproximal end108 of each of the first and second L-shapedarm members104 and106 includes first andsecond lever arms112 and114, respectively, that form themovable lever84 of theproximal handle70. Additionally, theproximal end108 of each of the first and second L-shapedarm members104 and106 includes alateral slot116 for operably connecting the first andsecond lever arms112 and114 with acontrol shaft118.
• Thedistal end110 of theactuating mechanism80 has a jack stand-like configuration. As shown inFIGS. 6A-B, thedistal end110 of each of the first and second L-shapedarm members104 and106 is adapted to securely mate with the first andsecond jaw members76 and78, respectively. Additionally, thedistal end110 of each of the first and second L-shapedarm members104 and106 includes a slot120 (FIG. 6B) adapted to receive afirst cross arm122, acentral cross arm123, and a second cross arm124.
• Theactuating mechanism80 additionally comprises acontrol shaft118 that is located between the first and second L-shapedarm members104 and106 and includes aproximal end126 and adistal end128. Theproximal end126 of thecontrol shaft118 includes aguide pin130 capable of mating with theslot120 of the first and second L-shapedarm members104 and106 and the lateral slot116 (FIG. 6A) of the first andsecond lever arms112 and114. Thedistal end128 of thecontrol shaft118 includes a plurality ofpins132 capable of mating with the first, central, and secondcross arms122,123 and124.
• As shown inFIG. 5, theactuating mechanism80 additionally includes wedge-shaped first andsecond plate members134 and136, each of which includes a first end138 and a second end140. The first end138 of each of the first andsecond plate members134 and136 is capable of mating with the first and second L-shapedarm members104 and106, respectively. Each of the first andsecond plate members134 and136 includes anaxial slot142 extending between the first and second ends138 and140. Theaxial slot142 of each of the first andsecond plate members134 and136 is capable of receiving a proximal end144 of first and seconddistal elements146 and148. The proximal end144 of each of the first and seconddistal elements146 and148 includes a laterally-extendingslot150 for mating with the central cross arm123 (FIG. 6B).
• Operation of theactuating mechanism80 begins by depressing themovable lever84. As themovable lever84 is depressed, the first andsecond lever arms112 and114 progressively urge theguide pin130 in a proximal direction so that thecontrol shaft118 moves laterally towards theproximal handle70. As thecontrol shaft118 is moved laterally, the first and secondcross arms122 and124 are pulled in a proximal direction along theslot120 of each of the first and second L-shapedarm members104 and106. Movement of the first and secondcross arms122 and124 causes the proximal end144 of each of the first and seconddistal elements146 and148 to move axially towards thecontrol shaft118 along theaxial slot142 of each of the first andsecond plate members134 and136. Consequently, the first and seconddistal elements146 and148 cause thesecond jaw member78 to move in an axial direction towards thefirst jaw member76.
• FIG. 7 illustrates another aspect of the present invention. InFIG. 7, amethod160 is provided for implanting a pre-sized PCA10 (FIG. 8) in a subject. The method160 (FIG. 7) can be used to replace diseased or damaged native chordae (not shown). Disease or damage to native chordae can be caused by a variety of factors, such as infection, trauma, and old age. Disease or damage to the native chordae can rupture of the chordae and lead to valvular regurgitation (e.g., mitral valve regurgitation). Advantageously, themethod160 provides a simple and effective means for replacing damaged or diseased chordae to mitigate or prevent cardiac valve dysfunction.
• Step162 and Step164 of themethod160 include providing apre-sized PCA10 andapparatus12 for implanting the pre-sized PCA, respectively. Thepre-sized PCA10 can be substantially identical to the pre-sized PCA inFIGS. 2A-C, and theapparatus12 can be substantially identical to the apparatus inFIG. 1B. Prior to replacing a diseased native chordae, the distance between a papillary muscle56 (FIG. 9) and a location on a mitral valve leaflet (not shown) is first measured. Access to the native chordae may be obtained by open-heart surgery, for example. During surgery, the diseased native chordae are inspected to determine the size of the pre-sizedprosthetic chordae20 needed to replace the diseased native chordae. Generally, the size of the pre-sizedprosthetic chordae20 needed will depend on the size of the heart (not shown), as well as the implantation site.
• A measuring device (not shown) is used to measure the distance between thepapillary muscle56 and the location on the mitral valve leaflet. For example, the measuring device can comprise a measuring device similar or identical to the measuring device disclosed in U.S. patent application Ser. No. 12/238,322. It will be appreciated that other types of measuring devices for measuring the distance between apapillary muscle56 and a location on a cardiac valve leaflet are known in the art. After determining the distance between thepapillary muscle56 and the location on the mitral valve leaflet, the diseased native chordae are resected and an appropriately-sized PCA10 selected for implantation.
• AtStep166, thepre-sized PCA10 is loaded onto thedistal applicator end72 of theapparatus12. As shown inFIG. 8, themale attachment unit14 is mated with thesecond jaw member78 by sliding the firstmale attachment member40 and the papillarymuscle penetration member18 into thesecond opening98 and thelongitudinal slot100, respectively. Additionally, thefemale securing member16 is mated with thefirst jaw member76 by sliding the female securing member into thefirst opening96 of the first jaw member.
• Once thepre-sized PCA10 is loaded onto thedistal applicator end72, the distal applicator end is positioned about thepapillary muscle56 atStep168. As shown inFIG. 9, the first andsecond jaw members76 and78 are disposed about opposite surfaces of thepapillary muscle56. Although the first andsecond jaw members76 and78 are shown inFIG. 9 as being positioned about the apical end of thepapillary muscle56, it will be appreciated that the first and second jaw members can be positioned about any other desired portion of the papillary muscle (e.g., the basal end).
• With the first andsecond jaw members76 and78 correctly positioned about thepapillary muscle56, thepre-sized PCA10 is then secured to the papillary muscle atStep170. To secure thepre-sized PCA10 to thepapillary muscle56, themovable lever84 is depressed to actuate thesecond jaw member78. As shown inFIG. 10, actuation of thesecond jaw member78 causes the papillarymuscle penetration member18 to pierce thepapillary muscle56 and be driven into thefemale securing member16. Thelever84 is depressed until thesecond jaw member78 naturally stops and the distal tip60 of the papillarymuscle penetration member18 is received by thefemale securing member16.
• Once thelever84 is completely depressed, thedistal applicator end72 is retracted at Step172. As shown inFIG. 11, the first andsecond openings96 and98 of the first andsecond jaw members76 and78 allows thefemale securing member16 and themale attachment unit14 to be slidably released from thedistal applicator end72, respectively, and remain affixed to the papillary muscle56 (FIG. 12). After retracting theapparatus12 from the subject's heart, each of the pre-sizedprosthetic chordae20 are securely attached to the mitrel valve leaflet as described in U.S. patent application Ser. No. 12/238,322, for example. With thepre-sized PCA10 implanted in the left ventricle (not shown), the mitrel valve leaflet is pulled back into proper alignment so that the mitrel valve can function properly and regurgitation through the valve is substantially reduced or prevented. Upon successful placement of thepre-sized PCA10, effective valve function is verified (i.e., proper leaflet coaptation) and the open-heart surgery is completed.
• From the above description of the invention, those skilled in the art will perceive improvements, changes and modifications. Such improvements, changes, and modifications are within the skill of the art and are intended to be covered by the appended claims.

Claims (20)

1. A pre-sized prosthetic chordae assembly comprising:

a male attachment unit comprising a plurality of pre-sized prosthetic chordae fixedly connected to at least one male attachment member and a papillary muscle penetration member that is connected to and extends substantially axial to said at least one male attachment member; and

a female securing member for receiving said papillary penetration member.

2. The pre-sized prosthetic chordae assembly ofclaim 1, wherein said male attachment unit further comprises first and second male attachment members, each of said first and second male attachment members having oppositely disposed first and second surfaces, said papillary muscle penetration member extending substantially axial to said first and second surfaces of each of said first and second male attachment members.

3. The pre-sized prosthetic chordae assembly ofclaim 2, wherein said papillary muscle penetration member includes a proximal end and a sharpened distal tip, said proximal end being securely connected to said first male attachment member.

4. The pre-sized prosthetic chordae assembly ofclaim 2, wherein each of said pre-sized prosthetic chordae is fixedly connected to said first surface of said second male attachment member.

5. The pre-sized prosthetic chordae assembly ofclaim 1, wherein each of said pre-sized prosthetic chordae further comprises:

a continuous first strand of a material having an arcuate first end portion and a second end portion that is formed into a knot; and

at least one rung that is axially spaced between said first and second end portions, said at least one rung including first and second ends that are securely connected to said first strand by first and second knots.

6. The pre-sized prosthetic chordae assembly ofclaim 2, wherein said second surface of said first male attachment member includes a backing for supporting said papillary muscle penetration member.

7. The pre-sized prosthetic chordae assembly ofclaim 2, wherein each of said second male attachment member and said female securing member include at least one channel extending therethrough.

8. The pre-sized prosthetic chordae assembly ofclaim 1, wherein said female securing member includes a protective member to prevent said distal tip of said papillary muscle penetration member from damaging a cardiac structure.

9. The pre-sized prosthetic chordae assembly ofclaim 1, wherein each of said at least one male attachment member and said female securing member comprises a pledget.

10. An apparatus for implanting a pre-sized prosthetic chordae assembly in a subject, said apparatus comprising:

a proximal handle;

a distal applicator end operably linked to said proximal handle via an intermediate portion that defines a longitudinal axis, said distal applicator end comprising opposable first and second jaw members, each of said first and second jaw members including a port for receiving the pre-sized prosthetic chordae assembly; and

an actuating mechanism that extends between said proximal handle and said distal applicator end, said actuating mechanism for actuating said second jaw member.

11. The apparatus ofclaim 10, wherein said port of each of said first and second jaw members is defined by an opening in fluid communication with opposing longitudinal slots that extend along a portion of each of said first and second jaw members.

12. The apparatus ofclaim 10, wherein said proximal handle includes an adjustment mechanism for controlling rotation of said distal applicator end about said longitudinal axis.

13. The apparatus ofclaim 10, wherein each of said first and second jaw members includes a proximal end and a distal end, said distal end of each of said first and second jaw members including first and second ports, respectively, for receiving a female securing member and a male attachment unit of the pre-sized prosthetic chordae assembly.

14. The apparatus ofclaim 13, wherein each of said first and second ports are defined by first and second openings, respectively, each of said first and second openings being in fluid communication with said opposing longitudinal slots, each of said opposing longitudinal slots extending along a portion of said distal end of each of said first and second jaw members.

15. A method for implanting a pre-sized prosthetic chordae assembly in a subject, said method comprising the steps of:

providing a pre-sized prosthetic chordae assembly, the pre-sized prosthetic chordae assembly including a male attachment unit comprising a plurality of pre-sized prosthetic chordae fixedly connected to at least one male attachment member and a papillary muscle penetration member that is connected to and extends substantially axial to the at least one male attachment member;

providing an apparatus for implanting the pre-sized prosthetic chordae assembly, the apparatus comprising a proximal handle, a distal applicator end operably linked to the proximal handle and comprising opposable first and second jaw members, and an actuating mechanism that extends between the proximal handle and the distal applicator end;

loading the female securing member and the male attachment unit onto the first and second jaw members, respectively;

positioning the distal applicator end about a papillary muscle so that the first and second jaw members are disposed about opposite sides of the papillary muscle;

operating the proximal handle to actuate the second jaw member such that the papillary penetration member pierces the papillary muscle and is received by the female securing member; and

retracting the distal applicator end so that the female securing member and the male attachment unit are slidably removed from the first and second jaw members, respectively, and remain implanted in the subject.

16. The method ofclaim 15, wherein said step of providing a pre-sized prosthetic chordae assembly further comprises providing a male attachment unit including first and second male attachment members, the plurality of pre-sized prosthetic chordae being fixedly sandwiched between the first and second male attachment members and the papillary penetration member extending substantially axial to the first and second male attachment members.

17. The method ofclaim 16, wherein said step of providing an apparatus for implanting the pre-sized prosthetic chordae assembly further comprises providing a distal applicator end that includes first and second jaw members that each have a proximal end and a distal end, the distal end of each of the first and second jaw members including first and second ports, respectively, each of the first and second ports being defined by first and second openings, respectively, each of the first and second openings being in fluid communication with opposing longitudinal slots, each of the opposing longitudinal slots extending along a portion of the distal end of each of the first and second jaw members.

18. The method ofclaim 17, wherein said step of loading the female securing member and the male attachment unit further comprises the steps of:

sliding the first male attachment member and the papillary muscle penetration member into the second opening and the longitudinal slot, respectively; and

sliding the female securing member into the first opening of the first jaw member.

19. The method ofclaim 15, wherein said step of operating the proximal handle further includes the step of depressing a movable lever of the proximal handle.

20. The method ofclaim 17, wherein said step of retracting the distal applicator end further comprises manipulating the apparatus so that the first male attachment member slides out of the longitudinal slot through the second opening and the female securing member simultaneously slides out of the first opening.

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